What is the public perspective surrounding labs?

It is safe to say that the public has never watched a public health emergency and associated testing unfold with as much attention as the Covid-19 pandemic. Add that to political content, social media and conflicting reports, and you get a shaken confidence in medical laboratory accuracy and credibility. It is important to understand that problems with test kits is a totally separate issue from the quality, safety, and reliability of the lab itself.

Specific problems occurred recently during COVID-19 testing that were a result of speedy FDA approvals and pressure to get tests out quickly. This was not the fault of lab facilities that were running the tests as instructed.

After piling on political content, social media and conflicting reports, it’s not difficult to end up with a shaken confidence in medical laboratory accuracy and credibility. However, we must evaluate the complete picture.

How Does the Lab Community Combat Public Perception?

Trusted lab results are the foundation of many diagnoses and treatment plans, and lab professionals join the ranks of trusted providers – such as doctors, nurses, and therapists. A very public testing saga unfolded as the country struggled to develop, deploy, and process testing in the largest pandemic of modern times. Daily scrutiny was placed on availability of testing, turnaround times, and accuracy. Social media memes were created, anecdotal individual stories went viral, and the world watched.

It is time to get back to educating the public about what lab professionals REALLY do, and the extreme regulatory standards they are held to.

A very public testing saga unfolded as the country struggled to develop, deploy, and process testing in the largest pandemic of modern times.

Lab Regulatory Compliance

What do live virus samples, transmissible disease samples, toxic chemicals, complex machinery, controlled substances, and critical results have in common?

A whole lot of safety and quality checks! The lab industry is no stranger to inspections and surveyors. Below is a list of regulatory bodies that monitor labs:

  • CLIA – Clinical Laboratory Improvement Amendments of 1988. All labs must be certified to accept Medicare or Medicaid payments.
  • Within CLIA, 3 federal agencies are responsible for enforcing the regulations – the FDA, CMS, and the CDC. Each has its own set of standards.
  • OSHA – Occupational Safety and Health Administration
  • TJC – The Joint Commission, a primary hospital and outpatient lab accreditation body.
  • EPA – Environmental Protection Agency
  • DHHS – Department of Health and Human Services

All that alphabet soup amounts to one of the highest regulated industries in the country! Initial accreditation is not enough, this is an ongoing practice that labs must maintain, with daily records of quality checks and procedures. Annual renewals and ongoing surprise inspections occur. Safety and quality are always top priorities!

Initial accreditation is not enough, this is an ongoing practice that labs must maintain, with daily records of quality checks and procedures.

Communicating Success

Labs, both private and public, can publish their awards, accreditations, and certifications in public forums. They can also use some of these as marketing strategies to inform the public and reestablish trust. There is no reason for the public to distrust lab results based on the lab itself. To find answers, individuals need to look deeper into the manufacture and approval processes for test kits.